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The goal of this clinical trial is to learn if brief mindfulness-based intervention (BMBI) is beneficial to participants suffering from painful temporomandibular disorders (TMD). The objectives of the research are:
Participants will:
Listen to the audio recordings 3 times a week, for 3 months when they are about to sleep.
Make 4 visits to the clinic: Baseline, 2 weeks, 1 month and 3 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Three 10-minute audio recordings (1, 2, 3) in MPEG-1 Audio Layer 3 (MP3) format consisting of relaxing music that mimic BMBI in duration but do not contain instructions specific to mindfulness training. |
|
| Brief Mindfulness-Based Intervention | Experimental | Three 10-minute audio recordings (A,B,C) for BMBI in MPEG-1 Audio Layer 3 (MP3) format that contain mindfulness training based on the breathing concept in a background of relaxing music. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham BMBI | Behavioral | Participants are requested to listen to the recordings 3 times a week, for 3 months (in a standardized sequence e.g., 1-2-3 and repeat) on Mondays-Wednesdays-Fridays. They are instructed to listen right before they sleep and encouraged to use them whenever they feel stressed or in pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Pain Intensity |
| Change from Baseline at 2 weeks, 1 month and 3 Months |
| Degree of Limitation of Jaw Function |
| Change from Baseline at 2 weeks, 1 month and 3 Months |
| Level of Psychological distress |
| Change from Baseline at 2 weeks, 1 month and 3 Months |
| Extent of Impact on Oral-health Related Quality of Life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Width of Mouth Opening | - Measurement of interincisal distance on reference teeth during maximum mouth opening without pain, with pain and with assistance | Change from Baseline at 2 weeks, 1 month and 3 Months |
| Number of Palpation Sites With Pain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siew Wui Chan, MClinDent (UM) | Contact | +60-379674540 | swuichan@um.edu.my | |
| Zuraiza Mohamad Zaini, MRACDS (Oral Med), PHD(London) | Contact | +60-379674869 | zuraiza@um.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Kathreena Kadir, MClinDent (OMFS)(Mal) | Faculty of Dentistry, Universiti Malaya | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya | Recruiting | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33884400 | Background | Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005. | |
| 30523705 | Background | McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5. |
| Label | URL |
|---|---|
| Diagnostic Criteria for Temporomandibular Disorders: Scoring Manual for Self-Report Instruments. | View source |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| BMBI | Behavioral | Participants are requested to listen to the recordings 3 times a week, for 3 months (in a standardized sequence e.g. A-B-C and repeat) on Mondays-Wednesdays-Fridays. They are instructed to listen right before they sleep and encouraged to use them whenever they feel stressed or in pain. |
|
| Change from Baseline at 2 weeks, 1 month and 3 Months |
| Change from Baseline at 2 weeks, 1 month and 3 Months |
| Change from Baseline at 2 weeks, 1 month and 3 Months |
| 29939051 | Background | Schumer MC, Lindsay EK, Creswell JD. Brief mindfulness training for negative affectivity: A systematic review and meta-analysis. J Consult Clin Psychol. 2018 Jul;86(7):569-583. doi: 10.1037/ccp0000324. |
| 24482784 | Background | Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. |
| 26040190 | Background | Yule PL, Durham J, Playford H, Moufti MA, Steele J, Steen N, Wassell RW, Ohrbach R. OHIP-TMDs: a patient-reported outcome measure for temporomandibular disorders. Community Dent Oral Epidemiol. 2015 Oct;43(5):461-70. doi: 10.1111/cdoe.12171. Epub 2015 Jun 4. |
| 22623334 | Background | Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |